ECLIPSE Study 9: Building resilience and recovery through enhancing cognition and quality
| ISRCTN | ISRCTN14678860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14678860 |
| Secondary identifying numbers | 20362 |
- Submission date
- 06/06/2016
- Registration date
- 06/06/2016
- Last edited
- 06/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Non-affective psychosis is the name given to a group of mental health conditions in which a person suffers from psychosis that is not related to mood. Schizophrenia and delusional disorders are examples of non-affective psychoses. These disorders involve a wide range of symptoms, including seeing or hearing things that are not there (hallucinations), having beliefs that do not reflect reality (delusions) and distinct changes in personality or behaviour. These symptoms can be very difficult for patients to deal with, often affecting the way they live their lives and their ability to work. The extent of cognitive problems (problems with thought, learning and/or memory) in people with these conditions is a good predictor functional recovery (how well someone can function in life), even with the best possible rehabilitation opportunities and medication. A new psychological treatment known as cognitive remediation (CRT) can improve both cognitive and functional recovery, including social relationships, work and studying. The ideal time to provide CRT is when a patient is being seen by the Early Intervention Services (for young people experiencing psychosis for the first time, and during the first three years following this first episode) as it is well known that it is more effective for younger people and may have larger effects on functioning if the intervention happens at the earliest opportunity. The aim of this study is to investigate the best way of putting into effect CRT for people in Early Intervention Services by assessing the degree that participants are able to achieve their personal goals.
Who can participate?
Adults aged between 16 and 45 who have a non-affective psychosis and have been attending an Early Intervention Service for at least three months or any individual within 5 years of their first episode of psychosis.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in intensive CRT. This involves receiving twice weekly individual therapy sessions for ten and a half weeks. Each session lasts for 60-180 minutes and involves 20-60 minutes of CRT with the therapist, 20-60 minutes of work learning how to apply CRT strategies to real life, and 20-60 minutes of independent CRT, done by the patient in their own time. Those in the second group take part in group CRT. This involves taking part in hour long sessions three times a week for 14 weeks in groups of four. At the start of the study, after the CRT programs are complete and then six months later, participants in both groups complete a number of questionnaires in order to evaluate how effective the treatment that they have received has been.
What are the possible benefits and risks of participating?
Participants benefit from receiving financial compensation for taking part in each of the research assessments (£7 per hour). Additionally, all participants will receive cognitive remediation therapy that may help their thinking skills and everyday activities. There are no notable risks involved with participating in this study.
Where is the study run from?
South London and Maudsley NHS Foundation Trust and nine other Mental Health NHS Trusts in England (UK)
When is the study starting and how long is it expected to run for?
January 2016 to March 2021
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Ms Tjasa Velikonja (public)
tjasa.velikonja@kcl.ac.uk
2. Professor Til Wykes (scientific)
til.wykes@kcl.ac.uk
Contact information
Public
Department of Psychology
King’s College London
Henry Wellcome Building
Institute of Psychiatry, Psychology & Neuroscience
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0003-0911-9262 |
|---|---|
| Phone | +44 (0)20 7848 0762 |
| emese.csipke@kcl.ac.uk |
Scientific
King's College London
Department of Psychology
Institute of Psychiatry, Psychology and Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0596 |
|---|---|
| til.wykes@kcl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not Specified, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Building Resilience and Recovery through Enhancing Cognition and quality of LIfe in the early PSychosEs (ECLIPSE) Study 9: Implementation of Remediation into Early Intervention Services |
| Study acronym | ECLIPSE |
| Study hypothesis | Study aim as of 21/07/2016: The aim of this study is to determine the best CRT implementation method for the majority of people in Early Intervention Services as assessed by the degree to which participants have achieved their personal goals (using the Goal Attainment Scale). Original study aim: The aim of this study is to determine the feasibility of implementing cognitive remediation therapy (CRT) into routine NHS early intervention services for psychosis and to establish the optimum implementation mode. |
| Ethics approval(s) | Camden and Kings Cross REC, 22/01/2016 00:00:00, ref: 15/LO/1960 |
| Condition | Non-affective psychosis |
| Intervention | Current Interventions as of 03/04/2019: All participants will be randomised to one of 2 trial arms, to receive either intensive CRT or CRT in a group setting. Both CRT interventions (intensive/group) will be carried out using computerised cognitive remediation (CIRCUITS Programme). There will be two regimes with different associated hours of therapist contact but all with 42 treatment hours. Intensive CRT: All participants are offered 10.5 weeks of twice weekly individual therapy. The sessions last for around 60-180 minutes and are in 3 parts: 1. 20-60 minutes of CRT with a therapist 2. 20-60 minutes of in vivo transfer work (i.e. putting CRT strategies into real life) with a therapist 3. 20-60 minutes of independent CRT, set up by the therapist on site, and done off-site in the patient’s own time Each patient receives up to 42 hours of CRT (21 with therapist, 21 independently) and 21 hours of in vivo transfer work (with a therapist). Group CRT: All participants attend 14 weeks of three times weekly group therapy (up to 42 hours of CRT in total). Participants will join the group as soon as possible following randomisation. Groups have closed membership, with 4 participants per group and each group will have one therapist. Each session lasts for 1 hour, with attendance for at least 20 minutes considered to have completed a session. Group sessions begin and end with group activities, relating to goal-setting and metacognition. During the rest of the session, patients work independently on CIRCuiTS tasks (at the same time) with the therapist offering help and support to individuals on an as-needed basis. Beside completing a pre-therapy (baseline) assessment in the 4 weeks prior to randomisation, post-therapy interviews/assessments will be conducted immediately following the 14-week intervention and 6 months after therapy using the same list of cognitive, clinical and other measures. Previous Interventions (as of 15/01/2018): Consenting patients will be randomised in blocks of 15 stratified by research site at week 0, week 14/15 and week 28/30, with randomisation in proportions 4:4:3:4 (group CRT/independent CRT/ intensive CRT/ treatment-as-usual). Alternative randomisation allocations will be used in the scenario where 15 participants cannot be recruited within the 12-week recruitment period, down to a minimum of 11 participants. This flexibility will allow more efficient use of time and resources (e.g. in case of unexpected participant’s withdrawal). All CRT interventions (intensive/group/independent) will be carried out using computerised cognitive remediation (CIRCUITS Programme). There will be three regimes with different associated hours of therapist contact but all with 42 treatment hours. Intensive CRT group: All participants are offered 10.5 weeks of twice weekly individual therapy. The sessions last for around 60-180 minutes and are in 3 parts: 1. 20-60 minutes of CRT with a therapist 2. 20-60 minutes of in vivo transfer work (i.e. putting CRT strategies into real life) with a therapist 3. 20-60 minutes of independent CRT, set up by the therapist on site, and done off-site in the patient’s own time Each patient receives up to 42 hours of CRT (21 with therapist, 21 independently) and 21 hours of in vivo transfer work (with a therapist). Group CRT group: All participants attend 14 weeks of three times weekly group therapy (up to 42 hours of CRT in total). The groups have closed membership and include 4 participants per group with one therapist leading the sessions. Each session lasts for 1 hour, with attendance for at least 20 minutes considered have completed a session. Group sessions begin and end with group activities, relating to goal-setting and metacognition. During the rest of the session, patients work independently on CIRCuiTS tasks (at the same time) with the therapist offering help and support to individuals on an as-needed basis. Independent CRT group: All participants are offered one individual session to get started. Following this, participants are offered up to 41 independent sessions (up to 42 hours of CRT in total). To support the independent sessions, the therapist offers telephone contact and/or attendance at daily drop-in sessions on an as needed basis (estimated average therapist time: 1 hour per fortnight). Drop-in sessions allow participants to attend over a set time period during the day, during which s/he will have access to a work-station, and the therapist will meet with them for about 5 minutes to make sure they have been able to set up a session and have any questions/ problems addressed. The participant then works independently for the rest of the session. Valid sessions last a minimum of 20 and a maximum of 60 minutes. Treatment as usual group: Participants receive standard, multi-modal treatment which consists of different therapies as defined as necessary by the treating team. Beside completing a pre-therapy (baseline) assessment in the 4 weeks prior to randomisation, post-therapy interviews/assessments will be conducted immediately following the 14 week intervention and 6 months after therapy using the same list of cognitive, clinical and other measures. Previous Interventions: Consenting patients will be randomised in blocks of 15 stratified by research site at week 0, week 14/15 and week 28/30, with randomisation in proportions 4:4:3:4 (group CRT/independent CRT/ intensive CRT/ treatment-as-usual). All CRT interventions (intensive/group/independent) will be carried out using computerised cognitive remediation (CIRCUITS Programme). There will be three regimes with different associated hours of therapist contact but all with 42 treatment hours. Intensive CRT group: All participants are offered 10.5 weeks of twice weekly individual therapy. The sessions last for around 60-180 minutes and are in 3 parts: 1. 20-60 minutes of CRT with a therapist 2. 20-60 minutes of in vivo transfer work (i.e. putting CRT strategies into real life) with a therapist 3. 20-60 minutes of independent CRT, set up by the therapist on site, and done off-site in the patient’s own time Each patient receives up to 42 hours of CRT (21 with therapist, 21 independently) and 21 hours of in vivo transfer work (with a therapist). Group CRT group: All participants attend 14 weeks of three times weekly group therapy (up to 42 hours of CRT in total). The groups have closed membership and include 4 participants per group with one therapist leading the sessions. Each session lasts for 1 hour, with attendance for at least 20 minutes considered have completed a session. Group sessions begin and end with group activities, relating to goal-setting and metacognition. During the rest of the session, patients work independently on CIRCuiTS tasks (at the same time) with the therapist offering help and support to individuals on an as-needed basis. Independent CRT group: All participants are offered one individual session to get started. Following this, participants are offered up to 41 independent sessions (up to 42 hours of CRT in total). To support the independent sessions, the therapist offers telephone contact and/or attendance at daily drop-in sessions on an as needed basis (estimated average therapist time: 1 hour per fortnight). Drop-in sessions allow participants to attend over a set time period during the day, during which s/he will have access to a work-station, and the therapist will meet with them for about 5 minutes to make sure they have been able to set up a session and have any questions/ problems addressed. The participant then works independently for the rest of the session. Valid sessions last a minimum of 20 and a maximum of 60 minutes. Treatment as usual group: Participants receive standard, multi-modal treatment which consists of different therapies as defined as necessary by the treating team. Beside completing a pre-therapy (baseline) assessment in the 4 weeks prior to randomisation, post-therapy interviews/assessments will be conducted immediately following the 14 week intervention and 6 months after therapy using the same list of cognitive, clinical and other measures. |
| Intervention type | Other |
| Primary outcome measure | Achievement of goals is measured using the Goal Attainment Scale at baseline, post-CRT and at 6 months follow up |
| Secondary outcome measures | 1. Total number of hours of structured activity per week is measured using The Time Use Survey at baseline, post-CRT and at 6 months follow up 2. Costs of health and social care use measured using The Client Service Receipt Inventory at baseline, post-CRT and at 6 months follow up 3. Quality-adjusted life years (QALYs) measured using the EQ-5D at baseline, post-CRT and at 6 months follow up 4. Self-esteem measured using the Rosenberg Self Esteem Scale at baseline, post-CRT and at 6 months follow up |
| Overall study start date | 01/01/2016 |
| Overall study end date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 438; UK Sample Size: 438 |
| Total final enrolment | 377 |
| Participant inclusion criteria | Current participant inclusion criteria as of 03/04/2019: 1. Attending an Early Intervention Service or any individual within 5 years of their first episode of psychosis. At least three months from the onset of the first episode of psychosis. 2. Aged between 16 and 45; 3. Research diagnosis of non-affective psychosis, i.e. schizophrenia, schizo-affective or schizophreniform disorder; 4. Ability to give informed consent. Previous participant inclusion criteria (as of 15/01/2018) 1. Attending an Early Intervention Service for at least three months 2. Aged between 16 and 45 3. Research diagnosis of non-affective psychosis, i.e. schizophrenia, schizoaffective or schizophreniform disorder 4. Ability to give informed consent Previous participant inclusion criteria 1. Attending an Early Intervention Service for at least six months 2. Aged between 16 and 35 3. Research diagnosis of non-affective psychosis, i.e. schizophrenia, schizoaffective or schizophreniform disorder 4. Ability to give informed consent |
| Participant exclusion criteria | Current participant exclusion criteria as of 03/04/2019: 1. Inability to communicate in English sufficiently to participate in cognitive testing; 2. Underlying organic/neurological condition affecting cognition (e.g. traumatic brain injury, seizure disorder); 3. Co-morbid diagnosis of learning disability. 4. A definitive diagnosis of bipolar disorder Previous participant exclusion criteria: 1. Inability to communicate in English sufficiently to participate in cognitive testing 2. Underlying organic/neurological condition affecting cognition(e.g. traumatic brain injury, seizure disorder) 3. Co-morbid diagnosis of learning disability |
| Recruitment start date | 06/06/2016 |
| Recruitment end date | 31/01/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Denmark Hill
London
SE5 8AZ
United Kingdom
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom
157 Barley Lane
Ilford
IG3 8XJ
United Kingdom
9 Alie Street
London
E1 8DE
United Kingdom
St. Anns Hospital
St Ann's Road
London
N15 3TH
United Kingdom
Birmingham
B4 6NH
United Kingdom
Wilsons Lane
Coventry
CV6 6NY
United Kingdom
Arundel Road
Worthing
BN13 3EP
United Kingdom
Drayton High Road
Norwich
NR6 5BE
United Kingdom
Fulbourn
Cambridge
CB21 5HH
United Kingdom
London
SW17 7DJ
United Kingdom
Sponsor information
University/education
PO05
Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AZ
England
United Kingdom
| Phone | +44 (0)20 7848 0251 |
|---|---|
| jennifer.liebscher@kcl.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication in journals aimed at providers and commissioners (HSJ), practitioners (The Psychologist; American Journal of Rehabilitation Practice) 2. Production of a training programme for therapists that is web-accessible and make this freely available together with the tests for good clinical practice |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/03/2018 | Yes | No | |
| Results article | 03/03/2023 | 06/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/03/2023: Publication reference added.
14/10/2022: The intention to publish date was changed from 30/04/2022 to 01/04/2023.
09/05/2022: The recruitment start date has been changed from 24/05/2016 to 06/06/2016.
09/08/2021: The intention to publish date was changed from 31/08/2021 to 30/04/2022.
04/06/2021: The following changes have been made:
1. The intention to publish date has been changed from 30/06/2021 to 31/08/2021.
2. The total final enrolment number has been added.
27/02/2020: The public contact has been changed and the plain English summary updated accordingly.
11/12/2019: The public contact has been changed.
04/11/2019: The recruitment end date has been changed from 31/10/2019 to 31/01/2020.
03/04/2019: The following changes were made to the trial record:
1. The plain English summary has been changed
2. The inclusion criteria have been changed
3. The exclusion criteria have been changed
4. The Participant inclusion criteria: Target number of participants was changed from "Planned Sample Size: 720; UK Sample Size: 720" to "Planned Sample Size: 438; UK Sample Size: 438"
5. The Total target enrolment has been changed from 720 to 438
6. The interventions have been changed.
7. The trial participating centre "South West London and St George's Mental Health NHS Trust" was added.
8. The trial participating centre "Birmingham and Solihull Mental Health NHS Foundation Trust" was changed to "Birmingham Women’s and Children’s NHS Foundation Trust".
9. The recruitment end date was changed from 24/05/2019 to 31/10/2019
10. The overall end date was changed from 01/10/2019 to 31/03/2021
11. The intention to publish date was changed from 01/10/2020 to 30/06/2021
02/04/2019: The condition has been changed from "Specialty: Mental Health, Primary sub-specialty: Psychosis - schizophrenia" to "Non-affective psychosis" following a request from the NIHR.
21/09/2018: Dr Velikonja Tjasa has been removed from the study contacts and Dr Leena Subramaniam has been added.
19/03/2018: Publication reference added.
15/01/2018: Participant inclusion criteria and interventions have been updated.
21/07/2016: The study hypothesis has been updated.
21/06/2016: Study status verified with principal investigator.
